Good for your health

Faced with international disasters, a new approach to auditing has been developed by the pharmaceutical sector. Martin VanTrieste explains

In January 2009, five quality professionals held a teleconference to respond to one of the most significant crises the pharmaceutical industry has ever faced – the heparin contamination of 2008 that allegedly caused 81 deaths.

The result of that conversation was a new consortium that became known as Rx-360. The mission of Rx-360 is to assure patient safety by enhancing product quality and authenticity throughout the supply chain, and one way it is doing this is through the sharing of audit data.

Rx-360

Since the first meeting, Rx-360 has made great progress. The consortium was incorporated as a non-profit organization in June 2009 and now has more than 40 member organizations consisting of suppliers, professional organizations and biotechnology and pharmaceutical companies. Rx-360 is designed to be inclusive, with branded and generic manufacturers, large and small companies, suppliers, vendors and professional organizations involved.

Rx-360 has nine active working groups focusing on creating infrastructure, monitoring the global environment, sharing information and sharing audits. Recently Rx-360 members have been busy setting up the infrastructure to initiate two pilot programmes: one conducting Rx-360 lead audits and the other collecting and sharing existing audit reports and responses.

To date, the consortium has:

  • developed a guideline for active pharmaceutical ingredients (APIs)
  • developed a supply chain security checklist and is drafting a guideline for basic chemicals and raw materials
  • designed the overall audit process for Rx-360 lead audits and created the documents and protocols needed to implement the audits and follow-up measures
  • developed an approach to requesting and qualifying auditors
  • developed a prototype database to hold audit information and is developing user requirements for and approaches to identifying a more mature database platform
  • designed a process for collecting existing audit reports and responses and implemented an overall quality management system for the pilot programmes.

Audit standards

The Rx-360 Audit Standards Working Group is split into several sub-groups to address the wide variety of standards that are required. There are six sub-groups: active pharmaceutical ingredients, excipients, supply chain security, basic chemicals, packaging and print. Of these sub-groups, the first four are active and standards are being finalized. Wherever possible, the groups are adopting existing standards and working closely with other organizations. These standards are now being used in the Rx-360 audit pilot programme to validate the whole auditing process.

Pilot programmes

In early March 2010, Rx-360 launched a pilot programme to share existing sponsor audits. The purpose of the pilot programme is to determine the value of sharing existing audits and the effectiveness of the audit sharing process to Rx-360 members.

The audit sharing process was designed to make available the wealth of supplier audit information that already exists within consortium member companies. The pilot involves approximately 25 suppliers from around the world and is being conducted to gauge suppliers’ willingness to share audit reports that are currently subject to confidentiality agreements with the original audit sponsor, as well as the usefulness of audit reports that have had competitively sensitive information redacted.

A second pilot programme for joint Rx-360 auditing is also now underway and involves approximately 20 suppliers. This pilot is primarily focused on testing the mechanics that Rx-360 has developed for the joint auditing programme. The plan is to have the joint auditing programme in place by autumn 2010.

About the author

Martin VanTrieste is the senior vice president of quality at Amgen. He co-founded Rx-360 and is currently the chairman of the board of directors